Brand Name | CUBBY BED ENCLOSED CANOPY BED |
Type of Device | PATIENT BED WITH CANOPY/RESTRAINTS |
Manufacturer (Section D) |
SENSORY MEDICAL INC |
1514 blake st. |
ste., 200 |
denver 80202 |
|
Manufacturer (Section G) |
SENSORY MEDICAL INC |
1514 blake st. |
ste., 200 |
denver CO 80202 |
|
Manufacturer Contact |
caleb
polley
|
1514 blake st. |
ste., 200 |
denver, CO 80202
|
8559642664
|
|
MDR Report Key | 16066376 |
MDR Text Key | 308289891 |
Report Number | 3020824629-2022-00008 |
Device Sequence Number | 1 |
Product Code |
OYS
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | 510(K)-EXMPT |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
12/29/2022 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/29/2022 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Lay User/Patient
|
Device Model Number | CUB2 |
Device Catalogue Number | CUB2 |
Device Lot Number | UNKNOWN |
Was Device Available for Evaluation? |
No
|
Date Manufacturer Received | 05/11/2022 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Removal/Correction Number | NO 21 USC 360I(F) ACTION |
Patient Sequence Number | 1 |